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ARTICLE IN PRESS
Braz J Otorhinolaryngol. 2017;xxx(xx):xxx---xxx

Brazilian Journal of

OTORHINOLARYNGOLOGY
www.bjorl.org

ORIGINAL ARTICLE

Comparison of the recovery rate of otomycosis using
betadine and clotrimazole topical treatment夽
Mohammad Reza Mofatteh a , Zahra Naseripour Yazdi b , Masoud Yousefi c ,
Mohammad Hasan Namaei c,∗

a
Birjand University of Medical Science, Faculty of Medicine, Department of ENT, Birjand, Iran
b
Birjand University of Medical Sciences, School of Medicine, Birjand, Iran
c
Infectious Diseases Research Center, Birjand University of Medical Science, Birjand, Iran

Received 21 February 2017; accepted 12 April 2017

KEYWORDS Abstract
Otomycosis; Introduction: Otomycosis is a common diseases that can be associated with many complications
Topical betadine; including involvement of the inner ear and mortality in rare cases. Management of otomycosis
Topical clotrimazole; can be challenging, and requires a close follow-up. Treatment options for otomycosis include
Recovery rate local debridement, local and systemic antifungal agents and utilization of topical antiseptics.
Objective: This study was designed to compare the recovery rate of otomycosis using two
therapeutic methods; topical betadine (Povidone-iodine) and clotrimazole.
Methods: In this single-blind clinical trial, 204 patients with otomycosis were selected using
a non-probability convenient sampling method and were randomly assigned to two treatment
groups of topical betadine and clotrimazole (102 patients in each group). Response to treatment
was assessed at 4, 10 and 20 days after treatment. Data were analyzed using the independent
t-test, Chi-Square and Fisher exact test in SPSS v.18 software, at a significance level of p < 0.05.
Results: The results showed that out of 204 patients with otomycosis, fungi type isolated
included Aspergillus in 151 cases (74%), and Candida albicans in 53 patients (26%). On the fourth
day after treatment, 13 patients (13.1%) in the group treated with betadine and 10 patients
(9.8%) in the group treated with clotrimazole showed a good clinical response to treatment
(p = 0.75). A good response to treatment was reported for 44 (43.1%) and 47 patients (46.1%)
on the tenth day after the treatment (p = 0.85); and 70 (68.6%) and 68 patients (67.6%) on the

夽 Please cite this article as: Mofatteh MR, Yazdi ZN, Yousefi M, Namaei MH. Comparison of the recovery rate of otomycosis using betadine

and clotrimazole topical treatment. Braz J Otorhinolaryngol. 2017. http://dx.doi.org/10.1016/j.bjorl.2017.04.004
Peer Review under the responsibility of Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial.
∗ Corresponding author.

E-mail: mhnamaei@hotmail.com (M.H. Namaei).

http://dx.doi.org/10.1016/j.bjorl.2017.04.004
1808-8694/© 2017 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. This is an open
access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

BJORL-525; No. of Pages 6

1%) no décimo dia após o tratamento (p = 0.0/).18. como Taxa de recuperação envolvimento da orelha interna e mortalidade em casos raros. Assim. qui-quadrado e teste exato de Fisher no software SPSS v. traumatic External ear infection is a common inflammation of the insemination of wood particles. scratching and manipulation of the ear canal local infections factors or as a manifestation of a systemic with non-sterile equipment. Introdução: A otomicose é uma das doenças comuns associadas a muitas complicações.05. Resultados: Os resultados mostraram que dos 204 pacientes com otomicose. Método: Neste ensaio clínico simples cego. living in dusty areas or wet disease.2 bathing. A resposta ao tratamento foi avaliada aos 4. Introduction otitis.0/). humidity of the ear canal after swimming and external ear canal in their lives. 10 e 20 dias após o tratamento.7. 13 pacientes (13.+Model ARTICLE IN PRESS 2 Mofatteh MR et al. respectively. Published by Elsevier Editora Ltda. As opções de tratamento para otomicose podem incluir desbridamento local. This is an open access article under the CC BY license (http:// creativecommons.46) no grupo tratado com betadina e clotrimazol. O resultado deste estudo apoia o uso de betadina como um antifúngico eficaz no tratamento da otomicose que pode ajudar a evitar o surgimento de organismos resistentes. and wax in the ear canal: expo- is a common cause of resistance to treatment of external sure of this mass to the tympanic membrane are causes of .6 Otomycosis is usually caused by predisposing factors. The response to treatment was thus not significantly different in the two groups. 204 pacientes com otomicose foram selecionados utilizando-se um método de amostragem de não probabilidade conveniente e randomizados para dois grupos de tratamento. a eficácia da betadina e do clotrimazol foi a mesma no trata- mento da otomicose.6%) e 68 pacientes (67. and fungal nail infection and dermatophitic lesions Fungal infection of external ear canal (Otomycosis) is a com.1%) e 47 pacientes (46. Conclusion: In the present study the efficacy of betadine and clotrimazole was the same for the treatment of otomycosis. Conclusão: No presente estudo.85). os tipos de fun- gos isolados incluíram Aspergillus em 151 casos (74%) e Candida albicans em 53 pacientes (26%). e 70 (68.6%) no vigésimo dia após o tratamento (p = 0. Uma boa resposta ao tratamento foi relatada para 44 (43. a resposta ao tratamento não foi significativamente diferente nos dois grupos. 90% of which is unilateral.1%) no grupo tratado com betadina e 10 pacientes (9. ing involvement of the inner ear with mortality in rare Nose and Throat (ENT) centers.2%5 of patients with Otomycosis is associated with many complications includ- signs and symptoms of external otitis media referred to Ear. PALAVRAS CHAVE Comparação entre taxa de recuperação de otomicose usando tratamento tópico com Otomicose. around the ear. agentes antifúngicos locais e sistêmicos e utilização de antissépticos tópicos. About 10% of people suffer from infection of the atmosphere.75). helping to avoid the emergence of resistant organisms. © 2017 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. plant materials and dirt into external ear canal and auricle that occurs due to various the ear canal.org/licenses/by/4. Objetivo: O objetivo deste estudo foi comparar a taxa de recuperação de otomicose utilizando dois métodos terapêuticos de betadina tópica (Povidona-iodo) e clotrimazol. The result of this study supports the use of betadine as an effective antifungal in otomycosis treatment. twentieth day after treatment (p = 0. com nível de significância de p < 0.8%) no grupo tratado com clotrimazol apresentaram boa resposta ao tratamento (p = 0.org/licenses/by/4. Publicado por Elsevier Editora Ltda.46) in the groups treated with betadine and clotrimazole. The infection is also the cases. respectivamente. epithelial cells. Os dados foram analisados utilizando o teste t independente.4 to 27. Este é um artigo Open Access sob uma licença CC BY (http:// creativecommons.1. such as entry of foreign bodies into the ear canal.8 mon disease accounting for 9%3. os medicamentos tópicos recomendados para o tratamento da otomicose. betadina e clotrimazol Betadina tópica. Resumo Clotrimazol tópico. No quarto dia após o tratamento. Formation of a fungus ball or fungal mass of cause of more than 30% of patients with ear discharge and mycelia. O tratamento da otomicose pode ser realmente desafiador e requer um acompanhamento rigoroso. com betadina tópica e com clotrimazol (102 pacientes em cada grupo). © 2017 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial.

a false veil of yeast in each group) by blocking randomization. 2014. both for patients and for ENT Samples were taken by a special speculum from the mass specialists. The disease presents many challenges. with chloramphenicol (Fina Daru. chronic was considered at p < 0. these were also separated in a sterile container and The main treatment of otomycosis is the removal of sent to specialized laboratories of mycology of Birjand Uni- visible debris and fungal elements. itching. in the presence of pus and follow-up. Germany) supplemented otomycosis and the most common species is Aspergillus. Neck skin and ear cartilage are also affected recruited into one of the two treatment groups (102 patients in acute infections.17 Given the importance of otomycosis treatment as one Recovery rate of otomycosis of the challenges facing ENT specialists. and may recur despite long-term treatment and in the ear canal. and external ear anomaly. and no answer (hypersecretion in the and recording in Iranian Registry of Clinical Trials by the external auditory canal). In chronic cases. of otomycosis. and obtaining informed consent. history of ear surgery. Germany) were done for the secondary overgrowth of fungus and increasing prevalence identification of yeast. The other group received 8 drops of antifungal Methods clotrimazole.+Model ARTICLE IN PRESS Recovery rate of otomycosis using betadine and clotrimazole 3 hearing loss. antiseptics.14.16. tables study were explained to the participants and they were and charts of distribution frequency and for the inferential recruited into the study if they were willing to partic- part. Topical medications rec. pants were selected from those referred to the ENT clinic Finally non-responders were considered treatment-resistant of Imam Reza and Vali-Asr Hospitals of Birjand Univer.05. so the vesicles on corn meal agar (Merck. be effective for the treatment of Candida infections. ommended for the control of this condition include steroids. stuffy Statistical analysis feeling associated with hearing loss and discharge were con- sidered suspicious for otomycosis. and the presence of associated with 23% recurrence rate. two weeks. 10 and 20 days after treatment by an ENT specialist who Study group did not know about the type of treatment. may mycosis. such as clotrimazole or nystatin. one patient group was treated with povidone- betadine and clotrimazole. Furthermore.18 sary use of antibacterial treatment for medial and external Furthermore. using fungal elements was considered as definite diagnosis of oto- antifungal solutions. The objectives of the In the present study. a total of 204 In this study. including: test were used in SPSS v. acidic solutions. The significant level otitis media with restriction of external ear canal. partial response (slight permission from the Ethics Committee of the University discharge but not dry). the partici. the patient’s ear was washed by the physician using 10 mL betadine solution 10% with a syringe. All 204 enrolled in different colors (depending on the type of fungus) may patients signed informed consent forms. Furthermore. On the other hand. germ tubes on human sera and production of otitis may cause fungal overgrowth in this area.12. Chi-square and Fisher exact ipate and had none of the exclusion criteria. widespread and unneces.18 software.13 Using boric In the laboratory. antifungal agents and driers. Patients with clinical signs and symptoms including pain. the independent t-test. but A portion of the sample was spread on a clean slide glass Aspergillus infections respond poorly to treatment. the samples were evaluated by a micro- acid in an alcohol solution for the treatment of disease is biology specialist using KOH method. Fungi were identified by standard procedures. mucus from ear.9---11 mucus. mass in the external auditory canal.15 This for direct examination and another sample inoculated in the is while a wide range of fungi have been reported to cause Sabouraud dextrose agar (Merck. otherwise treatment was continued. After receiving membrane and lack of secretion). sex. occur in the ear canal. to analyze the descriptive data. versity of Medical Sciences (BUMS). this study aimed to compare the recovery rate of otomycosis using topical In the study. The plates were incubated at room temperature for for treatment. The patients were categorized into three groups based on clinical response: This single-blind clinical trial was conducted on 204 patients good response (dry external ear canal and the tympanic with a definitive diagnosis of otomycosis. The mycosis can have a poor progno- sis in immunocompromised individuals. an appropriate treatment regimen is necessary growth. every eight hours. the treat- registration number (IRCT2014123020484N1). history of treatment with antifungal agents and corticosteroids. Iran) medium for fungal Therefore. Antifungal medications of otomycosis do not always cure Mycological investigation the disease and in addition treatment should improve the physiological signs of external ear canal. iodine so that at each visit. on the twentieth day and treatment regimen was continued sity of Medical Sciences during the first six months of with Tolnaftate and Violet de gentian. If complete response. Germany) supplemented adverse effects of using wide-spectrum antibiotics are the with tween 80 (Sigma-Aldrich. a total of 204 patients with otomycosis patients with otomycosis were enrolled into the study and were investigated in two treatment groups of betadine and . Results After recording the demographic characteristics such as age. ment was discontinued. especially in cases Collection of samples of cellular immunodeficiency and neutropenia. Patients were examined on 4.

45 40.43). Prevalence of ated with many complications including involvement of the Aspergillus spp.5 and inner ear and mortality in rare cases. In this study.20 In (46.8) 10 days Betadine 8 (7. and another study on 95 patients suspected of having the fun- 70 (68.5) 28 (27.75).6%) and 68 patients (67. Aspergillus spp. both for patients and for ENT specialists.46) in the group treated with betadine and Aspergillus was identified as the most common fungus grown clotrimazole.43 Gender 0.21 The results of our study were con- observed.5) a Values in table are mean ± SD.61 ± 15. Aspergillus species are one In our study. 13 patients (13.1) 0. Overall.37 ± 16.40 Male 40 (39.15 years old.1%) in the group treated with betadine conducted by Satish and colleagues showed that Aspergillus and 10 patients (9. Demographic characteristics Topical betadine group (%) Topical clotrimazole group (%) p-Value Age (years)a 38. A good response the immunocompetent group while Candida (53.9) Fungal agent 0. clotrimazole. Aspergillus species and C.4% and Candida albicans for 24.5 percentages of patients with otomycosis treated with many challenges.85 Clotrimazole 9 (8.11 according to age (p = 0. The disease presents 27.6) 13 (13. albicans for 26% (53 patients) of the infec- In the study. isolated from patients with otomycosis in 2003. 77 (75.1%) on the tenth day after the treatment (p = 0. 86 and twentieth day after treatment between two treatment (42.63 Aspergillus spp. Discussion tively. with the patients treated with betadine any side effects were a prevalence of 8.1) Female 62 (60.2) 46 (45.5) 68 (66.9. cases) and C.4) and the causative Results of this study showed that among 204 patients with agent of otomycosis (p = 0. The average age of patients in two groups treated with betadine and clotrimazole was 38.85).15%) of the patients with otomycosis were males and groups of betadine and clotrimazole (p < 0.8%) in the group treated with clotrimazole species (77%) was the most commonly isolated fungus in had a good response to treatment (p = 0.37 ± 16.63) between two treatment otomycosis. 72 cases of fungal cultures were positive and treatment (p = 0. tenth infections. and C. albicans was reported for 72. The albicans were reported as the most common species of fungi results demonstrated that on the fourth day after treat.3) 55 (55. was responsible for 74% (151 groups of betadine and clotrimazole (Table 1).6) 0.5% of otomycosis in Otomycosis is one of the common diseases that are associ- the patient group treated with betadine.7) 19 (18. 118 (57. This may be due to its high .1%) and 47 patients commonly isolated in the immunocompromised group. Table 2 Comparison of response to treatment on the fourth.8) 25 (24. albicans was in the next grade.4%) was to treatment was reported for 44 (43. of the most common causes of opportunistic invasive fungal ence in terms of response to treatment in the fourth.6) 70 (68. tenth and twentieth day after treatment in patients based on the treatment type.15 0.4) 74 (72.1) 20 days Betadine 13 (12.2%. and may recur despite the concern for long-term treatment Overall. respec.19 The study ment.4) 60 (58.8) 50 (49) 44 (43. Course of treatment Type of treatment Response to treatment p-Value No response (%) Partial response (%) Good response (%) a 0. sistent with the results above.61 ± 15.8) 56 (54. respectively.1%) and C. recovery rate of otomycosis was evaluated tion.6%) on the twentieth day after gal infection.7) a Three patients did not attend on the fourth day after the treatment. in two treatment groups of betadine and clotrimazole. Aspergillus spp.85%) were females.45 and 40. clotrimazole (102 patients in each group).1) Clotrimazole 32 (31. was responsible for 75.75 4 days Betadine 31 (31. Table 1 Comparison of demographic characteristics and distribution of fungi in patients with otomycosis based on the treatment type.1) 47 (46.05) (Table 2).8) 10 (9. the study showed no significant difference and follow-up. there was no statistically significant differ.46 Clotrimazole 9 (8. It is noteworthy that in none of in culture (41. sex (p = 0. study.5) Candida albicans 25 (24.+Model ARTICLE IN PRESS 4 Mofatteh MR et al. In the Pradhan et al.8) 46 (45. especially otomycosis.

6% of patients treated with beta- dine and 66. and bacterial and fungal resistance 15. Otomycosis with pus. ear fullness. Johnson JT.7%. Pulec JL. Manolopoulos L.25 In therapy. discharge from the ear. to treatment in the fourth.8:21776.16.265:139---45. and the appropriate 11. Vlastarakos PV. Comparing the ototoxicity. was evaluated on patients with otomycosis. Otomycosis: clinical fea- no difference in terms of response to treatment between tures and treatment implications. Robinson J. Asadi MA. All patients were examined for ear. cases. (Otoscopic Clinic). Lee K. 2115---22. 14. p.28. fullness were cured in 93.75:367---70. keeping the ear dry and the ear hygiene.135:787---91. Mousavi SAA. nocaine drops.+Model ARTICLE IN PRESS Recovery rate of otomycosis using betadine and clotrimazole 5 prevalence in dust and the acidic nature of the ear canal. Lippincott Williams & Wilkins. countries. Suction clearance and ment of otomycosis. 91. Oliveira NMC. Pontes ZBVdS. In addition. 2015. 2010. miconazole ointment and clotrimazole drop was compared 4. Such treatment can help to avoid to treatment. 2005. in the betadine patients group. Alikhah H. Finally. Therefore. Moghadam AY. in our study there was no statistically significant difference in terms of response The authors declare no conflicts of interest. Majidinia M.22 After completion of the treatment course in the present According to the results. the results showed that on the fourth day after treat. as a great number of Kreatsas G. p.3%. Betadine is also drops in the treatment of otomycosis. 2009.3%.27 In our study. 2008. Baradaran S. et al. Jundishapur J Microbiol. In a single-blind randomized clinical study. povidone-iodine were used as two drug regimens for treat. Chee G. 55. Ruckenstein M. Otomycosis in has been proven on chronic suppurative otitis media as the Turkey: predisposing factors. Otolaryngol Head Neck Surg. Head & Neck Surgery. Birjand.8:428---9.3%. clotrimazole and media. Kiakojuri K. Overall. This drug is a stable.14:457---64. Levine J. Forgie S. Infections of the external ear. and 46. Zarei A.1% of patients had a good response the emergence of resistant organisms. betadine can Cummings otolaryngology: head and neck surgery. Int J Pediatr Otorhinolaryngol.72:453---9. 657). Karaarslan A. 2008. Beers SL. 83. Paediatr Child Health.26 AZ. it can be Western area of Iran. Regarding the antifungal treatment effect on Acknowledgments otomycosis. Munguia R. Jundishapur J Microbiol. Roushan MRH. possibility of drug resistance in chronic infections. Ozcan M. Koujani ZS. 13. albicans. 2003. Karaarslan F.5% in comparison with clotrimazole 1% and lignocaine Sciences. Ozcan KM. Ong Y. Evaluating the strated that clotrimazole was effective against most yeasts effect of a mixture of alcohol and acetic acid for otomycosis and molds but tolnaftate had no impact on otomycosis. ment due to cost-effectiveness and appropriate therapeutic tively. Braz be noted that the basis of the treatment of otomycosis is J Otorhinolaryngol. the two treatment groups. 2009. Eur Arch Otorhinolaryngol. Clotrimazole is a medicine containing 2% topical miconazole versus the same combination with acidic azole groups that is used to treat infections. Brant J. Our ment. response to treatment one and two weeks after treatment. the symptoms of itching. Balkany T. the symptoms of itching. Ferekidis E.23 In another study. ear discharge and 2004. Coker NJ. ear pain in 86.6% and 58.8% of patients treated with betadine findings reinforce the use of betadine for otomycosis treat- and clotrimazole had partial response to treatment. Ann Acad Med Singapore. 2006. due to its low cost. several studies have been conducted so far. 6th ed be a good choice for otomycosis treatment in developing Philadelphia (PA): Elsevier Saunders. Essential Otolaryngology. Berjis N. 2002. 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The results of the final analysis showed that and there was 5.7% and tinnitus 3. Nikolopoulos TP. 10.1%. is safe. After the treat- ment period. aetiology and therapy. Kazemi A. Pediatr Emerg Care. tinnitus References and deafness were treated in 83. 2007. Ototopical antifungals and otomycosis: a treatment protocol should be considered according to the review. 462---511. Mahmoudabadi drug of choice in the treatment of otomycosis. Vrabec JT. Bailey BJ. Dehghani R. Otomycosis treatment requires early 9. Lima EdO. Iran (Grant no. Otomycosis: a retrospective study. Deguine C. and ear pain was treated in 100% of 1. Management of acute otitis different antifungal drugs. the effect of beta. Otitis externa review.38:749---53.34:330---4. This research was supported by Birjand University of Medical dine 7. Newlands SD. 2015. Treating common ear problems in pregnancy: what fungal infections of external ear are resistant to the avail. Jaafari A. 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